(93 days)
The Raycell X-ray Blood Irradiator is intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease according to applicable FDA, AABB, Health Canada, and European guidelines.
The Raycell X-ray Blood Irradiator is also intended for use in the irradiation of intra-operatively salvaged blood for cancer patients undergoing surgery to assist in the prevention of metastasis.
The Raycell is a self-contained shielded cabinet X-Ray Blood Irradiator. The device consists of a lead shielded chamber containing two vertically opposed x-ray tubes with provision for a sample canister holder between them, dual power supplies and a operator control panel. The operator places the blood products to be irradiated in the canister, opens the drawer, places the canister in the holder, closes the drawer and starts the irradiation cycle at the Operator Panel. The design of this device is substantially equivalent to the predicate device.
The provided text describes a 510(k) premarket notification for the Raycell Mk2 X-Ray Blood Irradiator. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Raycell, K051065) rather than presenting a clinical study to prove the device meets specific acceptance criteria based on patient outcomes or diagnostic performance.
Therefore, many of the requested elements for describing an acceptance criteria study (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance with ground truth) are not applicable or not present in this type of regulatory submission.
However, I can extract the information related to the device's technical specifications and safety/effectiveness testing against functional specifications, as this is the "study" referred to in the document.
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a direct table of quantitative acceptance criteria for clinical performance or diagnostic metrics. Instead, it focuses on demonstrating that the modified aspects of the Raycell Mk2 are equivalent or better than the predicate device's performance in terms of safety and technical functionality.
| Acceptance Criteria (General) | Reported Device Performance |
|---|---|
| Safety: | Safety: |
| Compliance with IEC 60601-1-2 (EMC) | Complies with IEC 60601-1-2: Edition 3.0 2007-03 |
| Compliance with IEC 60601-1 (Basic Safety & Essential Performance) | Complies with IEC 60601-1: Edition 3.0 2005 + CORR. 1 (2006) + CORR. 2 (2007) |
| External radiation fields (compared to predicate) | Decreased from the predicate design. |
| Electrical interlocks | Maintained. |
| New electro-mechanical safety interlock (for sliding drawer) | Added to prevent opening during x-ray generation. |
| Effectiveness/Functionality: | Effectiveness/Functionality: |
| Irradiate blood and blood products (to inactivate T-lymphocytes) | Uses the same x-ray tubes and high voltage generators as the predicate. Operates at a 25% higher power (4kW instead of 3.2kW). |
| Software control system | No changes to the control system software from the predicate design. |
| Dose delivered | Not explicitly stated, but the purpose of the device (inactivation of T-lymphocytes) implies it delivers a sufficient dose. The optional digital traceability has no impact on radiation times or dose delivered. |
| Ability to accommodate varying sample sizes | Available in 3.5L or 2L sample canister configurations (predicate was 1.5L). |
| Improved manufacturability and service access | Shielded irradiation chamber modified to improve manufacturability and access for service and maintenance. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified as a number of patient cases or blood samples in the context of a clinical study. The "test set" refers to the device itself undergoing engineering and safety validation.
- Data Provenance: The testing was likely conducted in a controlled laboratory or manufacturing environment by the manufacturer (Best Theratronics, Canada). It is not clinical data from patients or blood products in a real-world setting, but rather engineering verification and validation testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. As this is an engineering and safety validation of an irradiator, not a diagnostic or AI-based device, there were no clinical experts establishing "ground truth" for patient data. The "ground truth" here would be the physical and electrical parameters of the device meeting established engineering and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical adjudication method was used. The device's performance was evaluated against technical specifications and regulatory standards by engineers and quality assurance personnel.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not Applicable. This is an X-ray blood irradiator, not an AI-assisted diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a standalone medical device (X-ray blood irradiator). The "standalone performance" refers to the device's technical operation as described in the "Safety & Effectiveness" section against functional specifications and regulatory standards. There is no "algorithm only" performance to evaluate in the context of AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's acceptable performance was based on engineering specifications, international safety standards (IEC 60601 series), and comparison to the predicate device's proven functionality and safety. The device's ability to irradiate blood effectively for its stated purpose is an established physical principle and was likely assumed to be met based on using the same core X-ray technology as the predicate, with increased power.
8. The sample size for the training set:
- Not Applicable. This device does not use machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set for an AI model, this question is not relevant.
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